15 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HUAYI H035 BASIC WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014604589·TABLE WIDTH EXTENDER PAD 15 X 8 X 1 DELUX
Conformis Hip System
FDA UDI
Conformis, Inc.·00850268007873·ITOTAL HIP INSTRUMENT CASE, AUXILIARY
LEONE SPA
FDA UDI
LEONE SPA·08033707000969·MICRO SECT SCREWS U S/STEEL 4mm EXPANS.
Slimplicity Anterior Cervical Plate System
FDA UDI
PRECISION SPINE, INC.·00815362021095·1 Level 14mm Plate
Symmetry Malis®
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482140055·Symmetry® Bipolar Forceps; Straight; Titanium; ...
ACUVUE 2 BRAND (ETAFILCON A) CONTACT LENS, WITH UV BLOCKER TINTED (TO MASK OR ENHANCE THE NATURAL IRIS COLOR)
FDA 510(k)
FDA Class 2
·Ophthalmic
RS-4M+MUSCLE STIMULATOR
FDA 510(k)
FDA Class 2
·Physical Medicine
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 5, 2024
CUSTOM CONVENIENCE KIT
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code BYX·June 29, 2005
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 26, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 6, 2011
MEDFUSION 2001 SYRINGE INFUSION PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL MD·Product code FRN·July 17, 2008
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015